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Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.
Study Design Study Design: prospective non-interventional multicenter registry Screening: MSCT submitted to core lab & sizing strategy pre-declared (annular sizing, supra-annular sizing, mix of both methods) Follow up: MSCT and TTE to cooper lab
TAVI treatment Predilatation according to aortic annulus Dmin Evolut Pro (23-26-29) and Evolut R 34 XL Annular anchoring of the THV Postdilatation according to the operators' discretion Study Population All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Inclusion Criteria 1. Age ≥18 years. 2. NYHA≥2 and/or syncope and/or angina. 3. Patient judged by the Heart Team as indicated for TAVI. 4. Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.
5. Estimated life-expectancy>1 year.
Exclusion Criteria 1. Age <18 years 2. Asymptomatic patients 3. Estimated life expectancy<1 year 4. Pure aortic regurgitation. 5. LVEF<20% 6. No baseline MSCT evaluation. 7. Unsuitable aortic root anatomy for Evolut Pro or XL. 8. Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL. Primary Endpoint Valve performane Secondary endpoints 30 day and 1 year mortality Patient-prosthesis mismatch Ellipticity index at 30 days Follow-up 30 days: physical examination, ECG, TTE /MSCT upon operators' judgement
1 year: physical examination, ECG, TTE.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Implantation | Device | Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| Valve performance | effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate | 30 days |
| Valve performance | effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate | one year |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | 30 days and one year | |
| Patient-prosthesis mismatch | indexed effective area <0.65 cm2/m2 | 30 days and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Pasteur | Toulouse | Occitanie | 31076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37203860 | Result | Tchetche D, Ziviello F, De Biase C, De Backer O, Hovasse T, Leroux L, Petronio AS, Saint-Etienne C, Teles RC, Modine T, Sudre A, Teiger E, Mylotte D, Souteyrand G, Piazza N, Casassus F, Sondergaard L, Angelillis M, Nolasco T, Siddiqui S, Kardys I, Dumonteil N, Van Mieghem NM. Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry. EuroIntervention. 2023 Aug 21;19(6):502-511. doi: 10.4244/EIJ-D-23-00021. | |
| 30626202 |
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Mutual ananymized database. Substudies anticipated.
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| ID | Term |
|---|---|
| D000082882 | Bicuspid Aortic Valve Disease |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Ellipticity index at 30 days |
| 30 days |
| Derived |
| Tchetche D, de Biase C, van Gils L, Parma R, Ochala A, Lefevre T, Hovasse T, De Backer O, Sondergaard L, Bleiziffer S, Lange R, Kornowski R, Landes U, Norgaard BL, Biasco L, Philippart R, Molina-Martin de Nicolas J, Mylotte D, Lemee C, Dumonteil N, Van Mieghem NM. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019 Jan;12(1):e007107. doi: 10.1161/CIRCINTERVENTIONS.118.007107. |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |